To make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services (HHS) has issued a final rule specifying requirements for registering and reporting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting results. NIH also has issued a complementary policy for submitting summary results information for all NIH-funded clinical trials.
The U.S. Food and Drug Administration (FDA) has announced two draft guidances to support President Obama's Precision Medicine Initiative. The guidances will help provide oversight for tests based on next generation sequencing.
While generating large amounts of medical and genomic data may improve health, questions about access and use remain. To address these challenges, an NHGRI-funded project titled, Building the Medical Information Commons: Participant Engagement and Policy, held its first advisory committee meeting March 2-3 in Houston.
The use of human subjects in the field of genomics raises a number of key policy considerations that are being addressed at NHGRI and elsewhere. Learn more about his important topic with a new fact sheet from the Policy and Program Analysis Branch.
The NHGRI webpages for informed consent have recently been updated. Informed Consent for Genomics Reseach now offers easier access to informed consent resources, easier to read sample language entries and much more.